Research Summary

Dapivirine Ring, Oral PrEP Show Safety in Second-Trimester Pregnancy

Edited by:
Kate Young

Key Highlights

  • In MTN-042/DELIVER, 251 pregnant women without HIV were randomly assigned 4:1 to monthly dapivirine vaginal ring or daily oral tenofovir disoproxil fumarate–emtricitabine.
  • Twenty-eight mothers (11%) met the composite safety endpoint, but none of the events were related to product use; no maternal deaths or HIV seroconversions occurred.
  • Of 247 pregnancy outcomes, 233 (94%) were term deliveries, and pregnancy complications were uncommon.
  • Objective adherence and participant-reported satisfaction were high for both prevention methods, particularly for the dapivirine vaginal ring.

A phase 3b randomized trial published in The Lancet HIV found that both the dapivirine vaginal ring (DVR) and daily oral pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate–emtricitabine were safe and well tolerated when initiated during the second trimester of pregnancy. The findings address HIV prevention in pregnancy, a population at elevated risk of HIV acquisition.

In the MTN-042/DELIVER trial, investigators enrolled healthy pregnant women without HIV aged 18 to 40 years across Malawi, South Africa, Uganda, and Zimbabwe. Participants between 12 and 29 weeks’ gestation were randomly assigned in a 4:1 ratio to monthly DVR or daily oral PrEP, with use continuing until delivery or 42 weeks’ gestation. The primary safety outcome was a composite of serious adverse events, grade 3 or higher adverse events, and pregnancy outcomes categorized as term delivery, preterm delivery, or pregnancy loss before 20 weeks’ gestation. Pregnancy complications and adverse events were summarized descriptively.

Study Findings

Between July 12, 2022, and January 12, 2023, 251 participants were enrolled, with 202 assigned to DVR and 49 to oral PrEP. Median age was 24.0 years, and median gestational age at enrollment was 23.7 weeks.

Twenty-eight participants (11%) experienced events included in the composite safety endpoint; none were considered related to study product use. No maternal deaths or HIV seroconversions occurred during the study period.

Of 247 pregnancy outcomes, 233 (94%) were term deliveries (≥37 weeks’ gestation). Pregnancy complications were uncommon, and no infectious complications were reported. These findings are reported from the study only.

Clinical Implications

The study authors concluded that adverse pregnancy outcomes related to dapivirine vaginal ring and oral PrEP use were uncommon when initiated in the second trimester. These findings support the use of these HIV prevention strategies during pregnancy.

Expert Commentary

“Adverse pregnancy outcomes related to DVR and oral PrEP use were uncommon among women starting PrEP in the second trimester,” the researchers concluded. “These findings support the use of these preventive approaches during pregnancy.”

Reference
Mhlanga FG, Szydlo DW, Mayo AJ, et al. Safety, acceptability, and adherence to dapivirine vaginal ring and oral pre-exposure prophylaxis for HIV prevention in the second trimester of pregnancy: a multicountry, open-label, phase 3b randomised trial. Lancet HIV. 2026;13:e176-e184. doi:10.1016/S2352-3018(25)00307-8.